This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a Comparator QIV in children 6 months through 47 months of age.

The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is non-inferior to that of a Comparator QIV containing the same virus strains, in children 6 months through 47 months of age.

Results

On October 15, 2021, Seqirus announced that FluCelvax Quadrivalent was as safe and immunogenic as a standard quadrivalent seasonal influenza vaccine (QIV) in children six months to <four years of age during the U.S. 2019/20 influenza season. These data, presented at the Pediatric Academic Society (PAS) virtual Annual Meeting on May 1, 2021, represent the first U.S. Phase 3 study of a cell-based influenza vaccine in this population.

Based on these results the FDA has expanded the age indication for children as young as 6 months old.